Back Next-generation sequencing for adventitious virus detection in biologics: EDQM collaborates on article published in Biologicals

EDQM Strasbourg, France 08/11/2023
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The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored a report with a broad range of academics and interested parties, entitled “Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals”.

The article, published in Biologicals, reports on an International Alliance for Biological Standardization (IABS) conference held in September 2022 that underlined the significant progress made in next-generation sequencing (NGS, also called high-throughput sequencing, or HTS) in a context where the limitations of current testing methods for adventitious virus detection in biologics have become apparent. NGS, a powerful technology for broad virus detection, was further developed after it was found that, in certain cases, conventional techniques failed to detect novel or even known viruses. The complexity of NGS and its use nevertheless create challenges in regulation, standardisation, validation and bioinformatics, including in terms of data analysis, storage and follow-up strategies to confirm results.

The conference report provides details of the presentations and discussions that took place during the event, including:

  • the latest advances in NGS and their impact on biological product control;
  • the regulatory and health authority perspectives on using NGS for adventitious virus testing;
  • reference materials, NGS qualification and validation;
  • NGS applications for adventitious virus testing;
  • strategies for optimisation of NGS virus detection and follow-up of NGS signals ;
  • expectations for NGS implementation.

As described in the report, this conference was also an opportunity for EDQM representatives to present an update on the introduction of NGS in the European Pharmacopoeia. They also highlighted the ongoing work of the HTS Working Party to draft a dedicated general chapter High throughput sequencing for the detection of viral extraneous agents (2.6.41) that will describe both the NGS methods and guidelines for validation.

The EDQM’s participation in international conferences is an essential part of its forward-looking strategy. Not only does it ensure that the Organisation remains consistently relevant and at the cutting edge of technology, but it also provides an ideal forum for the EDQM to share its vast experience regarding the harmonisation of international standards and the feasibility of innovation in diverse national contexts. This in turn contributes to the broadest possible uptake of new technologies, for better health for all.

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